De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

Running, not enrolling · Phase 3

Conditions studied: Kidney Transplant; Complications, CMV

In brief

This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. There are two arms in the study: Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month. Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.

Key facts

Study ID

NCT06001320

Run by

Virginia Commonwealth University

People needed

30

Starts

2023-09-25

Expected to finish

2026-09-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• received valganciclovir for CMV prophylaxis
• Historical Control group:
• Exclusion
• Re-transplantation
• Panel of reactive antibody ≥80% at the time of transplant
• Positive cytotoxic cross match at the time of transplant
• Experimental Group Inclusion Criteria
• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• Ability to provide informed consent before any trial related activities

You may not qualify if…

• Re-transplantation
• Panel of reactive antibody ≥80% at the time of transplant
• Positive cytotoxic cross match at the time of transplant
• Pregnancy and Breastfeeding
• Prisoners
• Patients with hypersensitivity to acyclovir, valacyclovir or any of its components
• Patients with hypersensitivity to Letermovir or any of its components
• If Patients are taking any of these medications: pimozide, ergot alkaloids (ergotamine, dihydroergotamine), or pitavastatin/simvastatin co-administered with cyclosporine, we will work with the prescribing physician to find an appropriate replacement therapy which will not interfere with any study-related interventions. Otherwise, participants will be excluded from the study.

Where it is running

• VCU Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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